Severe adverse events (SAEs) monitoring and documentation is the responsibility of many key individuals in the clinical research study. Reconciling SAEs involves documenting those adverse events on the CRFs, as well as following up on them. To this end, both the clinical study coordinator and CRA play a central role in documenting those events. Here's how.

The Coordinator’s Role in SAEs Reconciliation

As soon as they become available, the study coordinator or study nurse will accurately record those events in the SAE report section of the case report form. The principal investigator will determine whether or not the events observed are related to the investigational drug (s). Those SAEs will be communicated to the sponsor, which in turn will notify the applicable regulatory authorities.

The CRA’s Role in SAE Reconciliation

The best way the monitor can reconcile SAEs is through conducting periodic monitoring visits. If SAEs are properly monitored at every single visit, SAE reconciliation should not be too cumbersome at the end. The CRA will evaluate the CRFs and determine whether SAEs were documented properly and followed up. Were those SAEs filed on time? Are there proper follow-up on those SAEs? Was the sponsor notified of the events in a timely manner? Download "Sample SAEs Report Reconciliation Checklist". Please share your thoughts below or share on your favorite social media website.

Relevant Articles:

Qualities of a Good Clinical Trial Monitor

Does the ICH Make it Hard to Break into Clinical Research?

Best Online Clinical Research Training Course Providers

Become a CRA At Last: Follow Three Simple and Powerful Steps!

Shocker: You May Never Become A CRA: Blame Your CRA Training Provider (Part 1)

Shocker: You May Never Become A CRA: Blame Your CRA Training Provider (Part 2)

Wanna Become a CRA? First Become a CRC!

Articles of Interest:

Professional Resumé Writing Services

Clinical Research Entry Level Resumé Tips: Is your Resumé Competitive?